10 Nov, 2023

Associate Quality Director

  • AstraZeneca
  • Gaithersburg, MD, USA
Operations Manager

Job Description

Join AstraZeneca and help us deliver life-changing medicines! Be among our employees who continue to make us a company that stands firmly among the leaders in BioPharmaceuticals.

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe.

In Operations, we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking.

Welcome to External Quality (EQ), a global Quality organization within AZ Operations where the community is vibrant, and we never stop developing. This is a place where you will feel included in the conversation, where every voice is heard and makes a difference. Operational Excellence in EQ has a vital role in protecting the AZ reputation and license to operate globally by constantly improving and maintaining the External Quality Management System.

Your role

In this key, you will provide day to day leadership and line management for quality managers within External Quality OPEX Operational QA team. You will be responsible to support the execution of quality events related to external suppliers and contract manufacturers. You will have a solid understanding of quality event process - SAP/EQV and have demonstrated ability for leading and coaching a team.

In this role you will:

  • Accountable for the management and development of the staff in their organization
  • Lead and coach your team in co-ordinating a range of quality events issued for EQ as a supplying site or coordinating site, and in the process of setting up new Quality Event flows for NPI, 3Ps and New Suppliers/Sites​
  • Support EQ Quality Management Systems (QE, AE, Product Security, IMTs, FAA)
  • Manage and maintain quality data and records in relevant quality management support systems (GQCLIMS, SAP and EQV) as required.
  • Effectively operate with the AZ Lean framework to drive efficiency and effectiveness across the business
  • Ability to make decisions through advice gathering, data and Quality requirements
  • QA review/approval of documents such as SOPs, quality events, change control requests, corrective and preventive action plans etc.


  • B.S. in Biology, Chemistry, Engineering or related fields
  • 2+ years in a supervisory role
  • Broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role
  • Strong knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
  • Proven track record of attracting and developing talent, building capability and driving performance in leadership roles
  • Excellent interpersonal skills (including, listening, writing, negotiation, facilitation, attention to detail and presentation skills)


  • Manufacturing
  • Multi-site/multi-functional experience
  • Strong problem solving skills
  • Strong negotiating/influencing skills

Interested – then come and join our journey

At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.

So, what’s next!

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Last applicable date 13th Nov, 2023. Curios to know more, get in touch with Sabina Erhardsson (Sabina.Erhardsson(a)astrazeneca.com).

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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